PROWLER 606-151FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704028598), received between Feb 6, 2017 and May 7, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K003925, K993266); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2022Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE WITH THE TARGET LOCATED ON THE MIDDLE CEREBRAL ARTERY (MCA), WHEN THE 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30573303) WAS TAKEN OUT IN ORDER TO INTRODUCE THE GUIDEWIRE, IT WAS NOT POSSIBLE TO INTRODUCE THE GUIDEWIRE. THE MICROCATHETER WAS REMOVED AND A SMALL KINK WAS NOTED ON THE IT. A NEW MICROCATHETER WAS USED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14325221 ↗
• MalfunctionJan 12, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, A CERENOVUS COIL WAS PLACED WITHOUT TROUBLE AND THEN A MICRUSFRAME14 7MMX11CM COIL (MFR140711, LOT UNKNOWN) WAS BEING USED AS THE SECOND COIL. HOWEVER, THE COIL COULD NOT BE ADVANCED WITHIN PRESHAPED PROWLER14 MICROCATHETER (606151FX, LOT UNKNOWN). THUS, THE COIL AND THE MC HAD TO BE WITHDRAWN. A NEW CERENOVUS COIL WAS USED WITH A NEW MC AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT APPEAR DAMAGED, IT COULD SIMPLY NOT BE PUSHED ANY FURTHER WITHIN THE MICROCATHETER. AFTER ADVANCEMENT WAS NOT POSSIBLE, WITHDRAWAL WAS TRIED BUT ALSO IMPOSSIBLE, THE COIL GOT STUCK. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235370 ↗
• MalfunctionJul 23, 2021Crack; Physical Resistance/Sticking; Crack; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE TARGETING A GIANT BASILAR ARTERY ANEURYSM, AFTER THE PHYSICIAN HAD ALREADY SUCCESSFULLY PLACED SEVEN (7) DIFFERENT COILS USING THE 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569), WHILE TRYING TO FINALIZE COILING USING THE 9MM X 25CM DELTAFILL 10 COIL (DLF100925 / 30395326), THERE WAS RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT ATTEMPT. THE PHYSICIAN REMOVED THE COIL AND MADE ANOTHER ATTEMPT TO ADVANCE THE COIL THE SMALLER COIL, A 5MM X 15CM DELTAFILL 10 (DLF100515 / 30452192). THE SAME RESISTANCE WAS ENCOUNTERED AND IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE MICROCATHETER AND THE PHYSICIAN COULD NOT REMOVE THE COIL. HE DECIDED TO REMOVE THE COIL/MICROCATHETER SYSTEM OUT OF THE PATIENT; THE PHYSICIAN CHECKED THE DEVICE ON THE TABLE AND NOTED THAT THE PROWLER 14 MICROCATHETER HAS A HOLE IN IT; THERE WAS A VISIBLE KINK ON THE PROWLER 14 MICROCATHETER. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE 9MM X 25CM DELTAFILL 10 COIL THAT WAS REMOVED WAS NOT STRETCHED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO BLOOD FLOW REDUCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220352 ↗
• MalfunctionDec 7, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSMAL SUBARACHNOID HEMORRHAGE, THE PROWLER 14 45TIP 2MRK (606151FX/30042648) MICROCATHETER WAS ADVANCED TO THE TARGET VESSEL, BUT THE 4X5 DELTAMAXX SR PLAT 18SYS (DMX18041520/L11600) THERMO-MECHANICAL COIL ¿HITCHED¿ INTO THE MICROCATHETER AND IT WAS NOT POSSIBLE TO ADVANCE OR RETRACT. THE SYSTEM WAS REMOVED AND REPLACED WITHOUT INCIDENT. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142340 ↗
• InjuryOct 17, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL COILING PROCEDURE OF AN UNRUPTURED ANEURYSM ON (B)(6) 2017, THE PHYSICIAN LOADED AN ORBIT GALAXY XTRASOFT 2.5X5 (640CX2505 / 17694774) INTO A PROWLER 14 MICROCATHETER (606151FX / 17610385). WHILE ADVANCING THROUGH THE CATHETER, THE PHYSICIAN MET SIGNIFICANT RESISTANCE AND COULD NOT PUSH THE COIL OUT OF THE END OF THE MICROCATHETER. THE COIL WAS REMOVED AND THE PHYSICIAN ATTEMPTED A SECOND GALAXY XTRASOFT 2.5X5 FROM THE SAME LOT (17694774) AND WAS MET WITH THE SAME ISSUE OF SIGNIFICANT RESISTANCE. THE SECOND COIL COULD NOT BE REMOVED AND AS A RESULT, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE SECOND COIL STILL STUCK INSIDE. A SECOND PROWLER 14 MICROCATHETER (UNKNOWN CATALOG AND LOT NUMBER) WAS INSERTED INTO THE ANEURYSM WITH THE ATTEMPT TO DELIVER AN AXIOM PRIME XTRASOFT 1.5X4 (A NON-CODMAN PRODUCT); THIS COIL WAS ALSO MET WITH RESISTANCE WITHIN THE NEW PROWLER MICROCATHETER. THE PHYSICIAN DECIDED TO ABANDON THE PROCEDURE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE INCIDENT. THE PATIENT¿S STATUS WAS REPORTED TO BE UNCHANGED AND NEUROLOGICALLY INTACT. PER THE HEALTHCARE PROFESSIONAL, THE DEVICES WERE USED AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6956285 ↗
• MalfunctionFeb 28, 2017Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COILING PROCEDURE OF A PCOM ANEURYSM, THE PHYSICIAN WAS UNABLE TO PUSH TWO 4 X 12 GALAXY COILS (640CF0412/175514192) INTO TWO PROWLER 14 MICROCATHETERS (606151FX/17669016), AND THE COILS AND CATHETERS WERE REPLACED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE GALAXY DELIVERY SYSTEM AND EXPERIENCED A LOT OF FRICTION DURING WITHDRAWAL. THE COIL WAS CONTAINED INSIDE OF THE SHEATH AS THE PHYSICIAN HAD NOT YET ADVANCED IT. WITH SOME FORCE, THE PHYSICIAN WAS ABLE TO PULL THE GALAXY COIL OUT OF THE PROWLER 14 MICROCATHETER. THE PHYSICIAN DISCARDED BOTH THE GALAXY COIL AND THE PROWLER 14 MICROCATHETER AND BEGAN THE PROCESS AGAIN WITH THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER. THE SAME ISSUE HAPPENED AGAIN; THE COIL WOULD NOT ADVANCE AS THE PHYSICIAN SAID IT BECAME STUCK IN THE MICROCATHETER AND THEY HAD TROUBLE PULLING IT BACK OUT. THE PHYSICIAN DISCARDED THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER AND COMPLETED THE PROCEDURE WITH A THIRD PROWLER 14 MICROCATHETER AND GALAXY 3.5X9 COIL. THE DIFFICULTY OCCURRED AT THE DISTAL PART OF THE BODY OF THE CATHETER; THE GALAXY COILS WERE ABLE TO BE ADVANCED TO THE DIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6366498 ↗
• MalfunctionFeb 6, 2017Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COILING PROCEDURE OF A PCOM ANEURYSM, THE PHYSICIAN WAS UNABLE TO PUSH TWO 4 X 12 GALAXY COILS (640CF0412/175514192) INTO TWO PROWLER 14 MICROCATHETERS (606151FX/17669016), AND THE COILS AND CATHETERS WERE REPLACED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE GALAXY DELIVERY SYSTEM AND EXPERIENCED A LOT OF FRICTION DURING WITHDRAWAL. THE COIL WAS CONTAINED INSIDE OF THE SHEATH AS THE PHYSICIAN HAD NOT YET ADVANCED IT. WITH SOME FORCE, THE PHYSICIAN WAS ABLE TO PULL THE GALAXY COIL OUT OF THE PROWLER 14 MICROCATHETER. THE PHYSICIAN DISCARDED BOTH THE GALAXY COIL AND THE PROWLER 14 MICROCATHETER AND BEGAN THE PROCESS AGAIN WITH THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER. THE SAME ISSUE HAPPENED AGAIN; THE COIL WOULD NOT ADVANCE AS THE PHYSICIAN SAID IT BECAME STUCK IN THE MICROCATHETER AND THEY HAD TROUBLE PULLING IT BACK OUT. THE PHYSICIAN DISCARDED THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER AND COMPLETED THE PROCEDURE WITH A THIRD PROWLER 14 MICROCATHETER AND GALAXY 3.5X9 COIL. THE DIFFICULTY OCCURRED AT THE DISTAL PART OF THE BODY OF THE CATHETER; THE GALAXY COILS WERE ABLE TO BE ADVANCED TO THE DIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6304983 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003925, K993266. One submission often covers many models, so check the product and lot details in each record.

• Z-0018-04 · Oct 19, 2001 · Terminated
  Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual